The U.S. Food and Drug Administration (FDA) has revealed that pharmaceutical giant Pfizer’s new vaccine carries a “potential risk” of causing a possibly fatal neurological disorder.
The news comes amid increasing concerns about adverse reactions to the company’s Covid shots.
Large numbers of people have reported some form of reaction to the jabs, with many suffering severe health issues such as heart attacks, strokes, or even sudden death.
Now the FDA has disclosed that another Pfizer vaccine can cause serious complications in recipients.
During a clinical trial, two older individuals contracted Guillain-Barré syndrome after receiving Pfizer’s Respiratory Syncytial Virus (RSV) shot.
These results caused the FDA to flag the RSV shot for carrying “an important potential risk” of causing the disease.
However, Pfizer is still seeking approval for general public use, despite the results from the trials.
Guillain-Barré syndrome is a rare disorder that causes your body’s immune system to attack your nerves, according to the Mayo Clinic.
While most people recover from Guillain-Barre syndrome, some severe cases can be fatal.
Other serious cases can result in paralysis.
There’s no known cure for Guillain-Barré syndrome.
Guillain-Barré syndrome after Covid vaccinations has been reported worldwide
Reports of people suffering life-threatening paralysis and death after the shots have been causing major concerns among the public.
Briefing documents released by the FDA on Friday flagged the two cases of the disorder and stated that Pfizer’s vaccine poses a potential risk.
The details emerged ahead of this week’s meeting of the Vaccines and Related Biological Products Advisory Committee.
“Given the temporal association and biological plausibility, FDA agrees with the assessments of the investigators that these events were possibly related to study vaccine,” the FDA stated in the documents.
“Therefore, [Guillain-Barré] is being considered an important potential risk.”
Two people in their 60s who received the RSV vaccine were diagnosed with Guillain-Barré syndrome in a phase 3 trial, which involved 20,000 recipients of the vaccine.
There were no instances of people suffering from the rare neurological disorder after receiving a placebo.
The briefing documents show that the FDA asked Pfizer to conduct a safety study if the RSV vaccine is approved in the spring.
No safety concerns were identified by Pfizer during the trial.
The company stated that it would carry out a safety study on its RSV vaccine if approved.
The FDA’s briefing documents state that Pfizer’s RSV vaccine was 85.7 percent effective at preventing severe illness.
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